RAPISCAN Solution for injection (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Rapiscan 400 microgram solution for injection.
Qualitative and quantitative composition
Each 5 ml vial contains 400 micrograms regadenoson (80 micrograms/ml). For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for injection. Clear, colourless solution.
Therapeutic indications
This medicinal product is for diagnostic use only. Rapiscan is a selective coronary vasodilator for use in adults as a pharmacological stress agent for: radionuclide myocardial perfusion imaging (MPI) ...
Posology and method of administration
Treatment with Rapiscan is restricted to use in a medical facility where cardiac monitoring and resuscitation equipment are available. Posology The recommended dose is a single injection of 400 micrograms ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Second or third degree atrioventricular (AV) block or sinus node dysfunction, unless these patients have a functioning ...
Special warnings and precautions for use
Regadenoson has the potential to cause serious and life-threatening reactions, including those listed below (see also section 4.8). Continuous ECG monitoring should be performed and vital signs should ...
Interaction with other medicinal products and other forms of interaction
Methylxanthines Methylxanthines (e.g., caffeine and theophylline) are non-specific adenosine receptor antagonists and may interfere with the vasodilation activity of regadenoson (see section 5.1). Patients ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of regadenoson in pregnant women. Animal studies on pre- and post-natal development have not been conducted. Fetotoxicity, but not teratogenicity, was ...
Effects on ability to drive and use machines
Regadenoson administration may result in adverse reactions such as dizziness, headache, and dyspnoea (see section 4.8) soon after administration. However, most adverse reactions are mild and transient, ...
Undesirable effects
Summary of the safety profile Adverse reactions in most patients receiving regadenoson in clinical trials were mild, transient (usually resolving within 30 minutes after receiving regadenoson) and required ...
Overdose
In a study of healthy volunteers, symptoms of flushing, dizziness and increased heart rate were assessed as intolerable at regadenoson doses greater than 0.02 mg/kg. Treatment Aminophylline may be used ...
Pharmacodynamic properties
Pharmacotherapeutic group: Cardiac therapy, other cardiac preparations ATC code: C01EB21 Mechanism of action Regadenoson is a low affinity agonist (Ki ≈ 1.3 μM) for the A<sub>2A</sub> adenosine receptor, ...
Pharmacokinetic properties
Absorption Regadenoson is administered by intravenous injection for pharmacologic stress radionuclide MPI. The regadenoson plasma concentration-time profile in healthy volunteers is multi-exponential in ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity, genotoxicity, or embryo-fetal development. Signs of maternal ...
List of excipients
Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Propylene glycol Disodium edetate Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 4 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
5 ml solution in a single use Type 1 glass vial with (butyl) rubber stopper and aluminium over-seal. Pack size of 1.
Special precautions for disposal and other handling
This medicinal product should be inspected visually for particulate matter and discolouration prior to administration. Any unused product or waste material should be disposed of in accordance with local ...
Marketing authorization holder
GE Healthcare AS, Nycoveien 1, NO-0485, Oslo, Norway
Marketing authorization number(s)
EU/1/10/643/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 06/09/2010 Date of latest renewal: 24/04/2015
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